Roles & Responsibilities
• Prepare, review, and support development of high-quality clinical and regulatory documents
• Assist in creation and review of CTD modules, Investigator’s Brochure (IB), protocols, ICFs, eCRF/CRFs, and safety reports
• Ensure documents comply with SOPs, regulatory guidelines, and approved plans
• Conduct literature searches and organize scientific data for clinical documentation
• Perform quality control (QC) checks on clinical and regulatory documents
• Support regulatory submission documentation activities
• Ensure timely delivery of assigned documentation tasks
Qualification
• B.Pharm or M.Pharm from a recognized university
Experience
• 2-3 years of experience in clinical research documentation
• Experience in a CRO or pharmaceutical industry preferred
Skills
• Knowledge of clinical trial documentation and regulatory requirements
• Strong scientific writing, review, and QC skills
• Ability to interpret clinical data and literature
• Good attention to detail and time management
• Strong communication and documentation skills
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations across India, USA, Canada, UK, Spain, and Poland. The company provides end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide, offering strong global exposure and long-term career growth opportunities in clinical research.
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